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Summary of the Product Characteristics Tirofiban hydrochloride Hikma Pharma GmbH SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT <TIROFIBAN>® *50 micrograms/mL Solution for infusion <TIROFIBAN>® *250 micrograms/mL Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION <TIROFIBAN> Solution: 1 ml of solution for infusion contains 56 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 50 micrograms Tirofiban. This medicinal product contains 31 mmol (or 715 mg) sodium per bag (250 ml). To be taken into consideration by patients on a controlled sodium diet. <TIROFIBAN> Concentrate: 1 ml of concentrate for solution for infusion contains 281 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 250 micrograms Tirofiban. 50 ml of concentrate for solution for infusion contains 14,05 mg of tirofiban hydrochloride monohydrate which is equivalent to 12,5 mg Tirofiban. This medicinal product contains less than 1 mmol sodium (23 mg) per vial (50 ml), i.e. essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM <TIROFIBAN> Solution: Solution for Infusion (250 ml bag) A clear, colourless solution. <TIROFIBAN> Concentrate: Concentrate for solution for infusion. A clear, colourless concentrated solution. * in the following document the abbreviated terms detailed below are used. • <TIROFIBAN> means <TIROFIBAN> Solution for Infusion or <TIROFIBAN> Concentrate for Solution for Infusion. • <TIROFIBAN> Solution will be used when referring to <TIROFIBAN> Solution for Infusion i.e. the 250 ml infusion bag. • <TIROFIBAN> Concentrate will be used when referring to <TIROFIBAN> Concentrate for Solution for Infusion i.e. the 50 ml vial. Page 1 Tirofiban hydrochloride Hikma Pharma GmbH 4 CLINICAL PARTICULARS 4.1 Therapeutic indications <TIROFIBAN> is indicated for the prevention of early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes. Patients most likely to benefit from <TIROFIBAN> treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early percutaneous coronary intervention (PCI) <Tirofiban> is also indicated for the reduction of major cardiovascular events in patients with acute myocardial infarction (STEMI) intended for primary PCI (see sections 4.2 and 5.1). <TIROFIBAN> is intended for use with acetylsalicylic acid (ASA) and unfractionated heparin. 4.2 Posology and method of administration This product is for hospital use only, by specialist physicians experienced in the management of acute coronary syndromes. <TIROFIBAN> concentrate for solution for infusion must be diluted before use. <Tirofiban> should be administered with unfractionated heparin and oral antiplatelet therapy, including ASA. Posology In patients who are managed with an early invasive strategy for NSTE-ACS but not planned to undergo angiography for at least 4 hours and up to 48 hours after diagnosis, tirofiban is given intravenously at an initial infusion rate of 0.4 microgram/kg/min for 30 minutes. At the end of the initial infusion, tirofiban should be continued at a maintenance infusion rate of 0.1 microgram/kg/min. Tirofiban should be given with unfractionated heparin (usually an intravenous bolus of 50-60 units [U/kg] simultaneously with the start of tirofiban therapy, then approximately 1,000 U per hour, titrated on the basis of the activated thromboplastin time [APTT], which should be about twice the normal value) and oral antiplatelet therapy, including but not limited to ASA (see section 5.1), unless contra-indicated. In NSTE-ACS patients planned to undergo PCI within the first 4 hours of diagnosis or in patients with acute myocardial infarction intended for primary PCI, <Tirofiban> should be administered utilizing an initial bolus of 25 microgram/kg given over a 3 minute period, followed by a continuous infusion at a rate of 0.15 microgram/kg/min for 18-24, and up to 48 hours. Tirofiban should be administered with unfractionated heparin (dosage as above) and oral antiplatelet therapy, including but not limited to ASA (see section 5.1), unless contra-indicated. Elderly No dosage adjustment is necessary for the elderly (see section 4.4). Patients with severe kidney failure In severe kidney failure (creatinine clearance <30 ml/min) the dosage of <TIROFIBAN> should be reduced by 50% (see sections 4.4 and 5.2). Paediatric population The safety and efficacy of <TIROFIBAN> in children aged <18 years have not been established. No data are available. Page 2 Tirofiban hydrochloride Hikma Pharma GmbH Table 1 is provided as a guide to dosage adjustment by weight. <TIROFIBAN> Concentrate must be diluted to the same strength as <TIROFIBAN> Solution, as noted under Instructions for Use. Table 1:Dosing Table 0.4 microgram/kg/min 0.4 microgram/kg/min 25 microgram/kg Dose Loading Dose Regimen Loading Dose Regimen Bolus Regimen Most Patients Severe Kidney Failure Most Patients Patient 30 min Maintenance 30 min Maintenance Bolus Maintenance Weight (kg) Loading Infusion Loading Infusion (ml) Infusion Infusion Rate Infusion Rate Rate Rate (ml/hr) Rate (ml/hr) (ml/hr) (ml/hr) (ml/hr) 30-37 16 4 8 2 17 6 38-45 20 5 10 3 21 7 46-54 24 6 12 3 25 9 55-62 28 7 14 4 29 11 63-70 32 8 16 4 33 12 71-79 36 9 18 5 38 14 80-87 40 10 20 5 42 15 88-95 44 11 22 6 46 16 96-104 48 12 24 6 50 18 105-112 52 13 26 7 54 20 113-120 56 14 28 7 58 21 121-128 60 15 30 8 62 22 129-137 64 16 32 8 67 24 138-145 68 17 34 9 71 25 146-153 72 18 36 9 75 27 25 microgram/kg Dose Bolus Regimen Severe Kidney Failure Bolus Maintenance Infusion Rate (ml) (ml/hr) 8 3 10 4 13 5 15 5 17 6 19 7 Page 3 Tirofiban hydrochloride Hikma Pharma GmbH 21 8 23 8 25 9 27 10 29 10 31 11 33 12 35 13 37 13 Start and duration of therapy with <TIROFIBAN> In patients who are managed with an early invasive strategy for NSTE-ACS but not planned to undergo angiography for at least 4 hours and up to 48 hours after diagnosis, the <TIROFIBAN> 0.4 microgram/kg/min loading dose regimen should be initiated upon diagnosis. The recommended duration of the maintenance infusion should be at least 48 hours. Infusion of <TIROFIBAN> and unfractionated heparin may be continued during coronary angiography and should be maintained for at least 12 hours and not more than 24 hours after angioplasty/atherectomy. Once a patient is clinically stable and no coronary intervention procedure is planned by the treating physician, the infusion should be discontinued. The entire duration of treatment should not exceed 108 hours. If the patient diagnosed with NSTE-ACS and managed with an invasive strategy undergoes angiography within 4 hours after the diagnosis, the <TIROFIBAN> 25 microgram/kg dose bolus regimen should be initiated at the start of PCI with the infusion continued for 12-24 hours and up to 48 hours. In patients with acute myocardial infarction intended for primary PCI, the 25 microgram/kg dose bolus regimen should be initiated as soon as possible after diagnosis. Concurrent therapy (unfractionated heparin, oral antiplatelet therapy including ASA) Treatment with unfractionated heparin is initiated with an i.v. bolus of 50-60 U/kg and then continued with a maintenance infusion of 1,000 U per hour. The heparin dosage is titrated to maintain an APTT of approximately twice the normal value. Unless contra-indicated, all patients should receive oral antiplatelet agents, including but not limited to ASA, before the start of <TIROFIBAN> (see section 5.1). This medication should be continued at least for the duration of the infusion of <TIROFIBAN>. Most studies investigating the administration of tirofiban hydrochloride as an adjunct to PCI have used ASA in combination with clopidogrel as oral antiplatelet therapy. The efficacy of the combination of tirofiban hydrochloride with either prasugrel or ticagrelor has not been established in randomised controlled trials. If angioplasty (PCI) is required, heparin should be stopped after PCI, and the sheaths should be withdrawn once coagulation has returned to normal, e.g. when the activated clotting time (ACT) is less than 180 seconds (usually 2-6 hours after discontinuation of heparin). Method of administration Page 4 Tirofiban hydrochloride Hikma Pharma GmbH <TIROFIBAN> SOLUTION Instructions for use Do not withdraw solution directly from the infusion bag with a syringe. To open: Tear foil overpouch or plastic dust cover down side at slit and remove infusion bag. Some opacity of the plastic due to moisture absorption during the sterilisation process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not use unless solution is clear and seal is intact. Do not add supplementary medication or withdraw solution directly from the bag with a syringe. CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Preparation for administration 1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set. Use according to the dosage table above. Where the solution and container permit, parenteral drugs should be inspected for visible particles or discoloration before use.
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